Diabetes Mellitus, Type 2
Conditions
Keywords
diabetes
Brief summary
The purpose of this study is to determine if albiglutide is safe and effective in the treatment of type 2 diabetes.
Interventions
BIOLOGICALalbiglutide
albiglutide
DRUGsitagliptin
sitagliptin
DRUGglimepiride
Glimepiride
DRUGmetformin
Metformin
BIOLOGICALplacebo albiglutide
placebo to match albiglutide
placebo to match sitagliptin
DRUGplacebo glimepiride
placebo to match glimepiride
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* type 2 diabetes * BMI 20-45kg/m2 inclusive
Exclusion criteria
* females who are pregnant, lactating or \<6 weeks post-partum * current symptomatic heart failure (NYHA Class III or IV)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline (BL) in Glycosylated Hemoglobin (HbA1c) at Week 104 | Baseline and Week 104 | HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3-month period. The BL HbA1c value is defined as the last non-missing value before the start of treatment. Change from BL was calculated as the value at Week 104 minus the value at BL. Based on analysis of covariance (ANCOVA): change = treatment + BL HbA1c + prior myocardial infarction history + age category + region. Difference of least squares means (albiglutide - placebo, albiglutide - sitagliptin, albiglutide - glimepiride) is from the ANCOVA model. The last observation carried forward (LOCF) method was used to impute missing post-Baseline HbA1c values; the last non-missing post-BL on-treatment measurement was used to impute the missing measurement. HbA1c values obtained after hyperglycemic rescue were treated as missing and were replaced with pre-rescue values. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Fasting Plasma Glucose (FPG) at Week 104 | Baseline and Week 104 | The FPG test measures blood sugar levels after the participant has not eaten (fasted) for 12 to 14 hours. The Baseline FPG value is the last non-missing value before the start of treatment. The LOCF method was used to impute missing post-Baseline FPG values. FPG values obtained after hyperglycemia rescue were treated as missing and replaced with pre-rescue values. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Based on ANCOVA: change = treatment + Baseline FPG + Baseline HbA1c category + prior myocardial infarction history + age category + region. |
| Change From Baseline in FPG at Week 156 | Baseline and Week 156 | The FPG test measures blood sugar levels after the participant has not eaten (fasted) for 12 to 14 hours. The Baseline FPG value is the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. This analysis used observed FPG values excluding those obtained after hyperglycemia rescue; no missing data imputation was performed. |
| Number of Participants Who Achieved Clinically Meaningful HbA1c Response Levels of <6.5%, <7%, and <7.5% at Week 104 | Week 104 | The number of participants who achieved the HbA1c treatment goal (i.e., HbA1c response levels of \<6.5%, \<7%, and \<7.5% at Week 52) were assessed. |
| Change From Baseline in HbA1c at Week 156 | Baseline and Week 156 | HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3-month period. Baseline HbA1c value is defined as the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. This analysis used observed HbA1c values, excluding those obtained after hyperglycemia rescue; no missing data imputation was performed . |
| Time to Hyperglycemia Rescue | From the start of study medication until the end of the treatment (up to Week 156) | Participants who experienced persistent hyperglycemia (high blood glucose) could have qualified for hyperglycemia rescue.The conditions for hyperglycemic rescue were as follows: FPG \>=280 milligrams/deciliter (mg/dL) between \>=Week 2 and \<Week 4; FPG \>=250 mg/dL between \>=Week 4 and \<Week 12; HbA1c \>=8.5% and a \<=0.5% reduction from Baseline between \>=Week 12 and \<Week 24; HbA1c \>=8.5% between \>=Week 24 and \<Week 48; HbA1c \>=8.0% between \>= Week 48 and \<Week 156. Participants could have been rescued at any time on or after Week 2. Time to hyperglycemia rescue is defined as the time between the date of the first dose of study medication and the date of hyperglycemia rescue plus 1 day, or the time between the date of the first dose of study medication and the date of the last visit during the active treatment period plus 1 day for participants not requiring rescue. This time was divided by 7 to express the result in week |
| Change From Baseline in Body Weight at Week 104 | Baseline and Week 104 | The Baseline value is the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline weight minus the Baseline weight. The LOCF method was used to impute missing post-Baseline weight values. Weight values obtained after hyperglycemia rescue were treated as missing and replaced with prerescue values. Based on ANCOVA: change = treatment + Baseline weight + Baseline HbA1c category + prior myocardial infarction history + age category + region. |
| Change From Baseline in Body Weight at Week 156 | Baseline and Week 156 | The Baseline value is the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline weight minus the Baseline weight. This analysis used observed body weight values excluding those obtained after hyperglycemia rescue; no missing data imputation was performed. |
| Number of Participants Who Achieved Clinically Meaningful HbA1c Response Levels of <6.5%, <7%, and <7.5% at Week 156 | Week 156 | The number of participants who achieved the HbA1c treatment goal (i.e., HbA1c response levels of \<6.5%, \<7%, and \<7.5% at Week 156) were assessed. |
Countries
Albania, Germany, Hong Kong, Mexico, Peru, Philippines, Russia, South Africa, Spain, United Kingdom, United States
Participant flow
Pre-assignment details
Eligible participants (par.) entered a 2-week Screening Period, a 4-week Run-in/Stabilization Period, a 156-week Treatment Period, and a 8-week post-treatment Follow-up Period. A total of 1525 par. were screened, 1049 were randomized and 1012 par. received at least 1 dose of study treatment.
Participants by arm
| Arm | Count |
|---|---|
| Placebo Plus Metformin Participants received metformin \>=1500 milligrams (mg) daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching sitagliptin placebo plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period. | 101 |
| Sitagliptin 100 mg Plus Metformin Participants received sitagliptin 100 mg daily plus metformin \>=1500 mg daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period. | 302 |
| Glimepiride 2 mg Plus Metformin Participants received glimepiride 2 mg daily (with masked up-titration to 4 mg daily if required) plus metformin \>=1500 mg daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching sitagliptin placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period. | 307 |
| Albiglutide 30 mg Plus Metformin Participants received albiglutide 30 mg weekly (with masked up-titration to 50 mg weekly if required) as a subcutaneous injection via a fully disposable pen injector system plus metformin \>=1500 mg daily plus matching sitagliptin placebo plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period. | 302 |
| Total | 1,012 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Follow-up Period (8 Weeks) | Adverse Event | 0 | 0 | 3 | 1 |
| Follow-up Period (8 Weeks) | Did Not Enter Follow-up Period | 5 | 7 | 12 | 7 |
| Follow-up Period (8 Weeks) | ICF Withdrawn | 0 | 1 | 0 | 0 |
| Follow-up Period (8 Weeks) | Investigator Stopped Study at Site | 0 | 1 | 0 | 0 |
| Follow-up Period (8 Weeks) | Lost to Follow-up | 6 | 28 | 22 | 24 |
| Follow-up Period (8 Weeks) | Missing | 1 | 2 | 1 | 1 |
| Follow-up Period (8 Weeks) | Noncompliance | 2 | 8 | 5 | 5 |
| Follow-up Period (8 Weeks) | Physician Decision | 1 | 1 | 1 | 1 |
| Follow-up Period (8 Weeks) | Subject Moved out of Town | 0 | 0 | 0 | 1 |
| Follow-up Period (8 Weeks) | Subject Withdrawn from Follow-up | 8 | 13 | 14 | 14 |
| Follow-up Period (8 Weeks) | Termination of Study/Site by GSK | 3 | 4 | 6 | 4 |
| Treatment Period (156 Weeks) | Adverse Event | 5 | 13 | 17 | 25 |
| Treatment Period (156 Weeks) | Lost to Follow-up | 4 | 16 | 15 | 13 |
| Treatment Period (156 Weeks) | Missing Active Treatment Status | 1 | 0 | 0 | 0 |
| Treatment Period (156 Weeks) | Noncompliance | 9 | 13 | 12 | 6 |
| Treatment Period (156 Weeks) | Patient and PI Decision to Discontinue | 0 | 1 | 0 | 0 |
| Treatment Period (156 Weeks) | Physician Decision | 1 | 2 | 1 | 2 |
| Treatment Period (156 Weeks) | PI Decided for Safety Purpose | 0 | 0 | 1 | 0 |
| Treatment Period (156 Weeks) | Poor Glycemic Control | 0 | 0 | 0 | 1 |
| Treatment Period (156 Weeks) | Poor Therapeutic Response | 1 | 0 | 0 | 0 |
| Treatment Period (156 Weeks) | Pregnancy | 0 | 0 | 1 | 0 |
| Treatment Period (156 Weeks) | Protocol Violation | 1 | 6 | 6 | 5 |
| Treatment Period (156 Weeks) | Severe or Repeated Hypoglycaemia | 0 | 0 | 1 | 0 |
| Treatment Period (156 Weeks) | Site closed | 0 | 0 | 1 | 0 |
| Treatment Period (156 Weeks) | Site Closed and Subject Withdrew Consent | 1 | 0 | 0 | 0 |
| Treatment Period (156 Weeks) | Subject Migrated to Other Country | 0 | 1 | 0 | 1 |
| Treatment Period (156 Weeks) | Termination of Study/Site by GSK | 3 | 5 | 5 | 4 |
| Treatment Period (156 Weeks) | Withdrawal by Subject | 20 | 55 | 56 | 53 |
Baseline characteristics
| Characteristic | Placebo Plus Metformin | Sitagliptin 100 mg Plus Metformin | Glimepiride 2 mg Plus Metformin | Albiglutide 30 mg Plus Metformin | Total |
|---|---|---|---|---|---|
| Age, Continuous | 56.1 Years STANDARD_DEVIATION 10.01 | 54.3 Years STANDARD_DEVIATION 9.81 | 54.4 Years STANDARD_DEVIATION 9.97 | 54.3 Years STANDARD_DEVIATION 10.12 | 54.5 Years STANDARD_DEVIATION 9.97 |
| Gender Female | 51 Participants | 163 Participants | 149 Participants | 167 Participants | 530 Participants |
| Gender Male | 50 Participants | 139 Participants | 158 Participants | 135 Participants | 482 Participants |
| Race/Ethnicity, Customized African American/African Heritage | 23 Participants | 35 Participants | 39 Participants | 53 Participants | 150 Participants |
| Race/Ethnicity, Customized American Indian or Alaskan Native | 9 Participants | 22 Participants | 25 Participants | 17 Participants | 73 Participants |
| Race/Ethnicity, Customized Asian - Central/South Asian Heritage | 1 Participants | 7 Participants | 3 Participants | 2 Participants | 13 Participants |
| Race/Ethnicity, Customized Asian - East Asian Heritage | 0 Participants | 2 Participants | 3 Participants | 5 Participants | 10 Participants |
| Race/Ethnicity, Customized Asian - Japanese Heritage | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 2 Participants |
| Race/Ethnicity, Customized Asian - South East Asian Heritage | 3 Participants | 11 Participants | 9 Participants | 11 Participants | 34 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 2 Participants |
| Race/Ethnicity, Customized White - Arabic/North African Heritage | 0 Participants | 1 Participants | 9 Participants | 3 Participants | 13 Participants |
| Race/Ethnicity, Customized White - White/Caucasian/European Heritage | 64 Participants | 225 Participants | 220 Participants | 214 Participants | 723 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 75 / 101 | 229 / 302 | 258 / 307 | 242 / 302 |
| serious Total, serious adverse events | 15 / 101 | 32 / 302 | 36 / 307 | 44 / 302 |
Outcome results
Primary
Change From Baseline (BL) in Glycosylated Hemoglobin (HbA1c) at Week 104
HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3-month period. The BL HbA1c value is defined as the last non-missing value before the start of treatment. Change from BL was calculated as the value at Week 104 minus the value at BL. Based on analysis of covariance (ANCOVA): change = treatment + BL HbA1c + prior myocardial infarction history + age category + region. Difference of least squares means (albiglutide - placebo, albiglutide - sitagliptin, albiglutide - glimepiride) is from the ANCOVA model. The last observation carried forward (LOCF) method was used to impute missing post-Baseline HbA1c values; the last non-missing post-BL on-treatment measurement was used to impute the missing measurement. HbA1c values obtained after hyperglycemic rescue were treated as missing and were replaced with pre-rescue values.
Time frame: Baseline and Week 104
Population: Intent-to-Treat (ITT) Population with LOCF: all randomized par. who received \>=1 dose of study medication and who had a BL assessment and \>=1 post-BL assessment of HbA1c. Only par. with a value at BL and at the specified visit were analyzed. Values were carried forward for par. who were rescued or discontinued from active treatment before Week 104.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo Plus Metformin | Change From Baseline (BL) in Glycosylated Hemoglobin (HbA1c) at Week 104 | 0.27 Percentage of HbA1c in the blood | Standard Error 0.113 |
| Sitagliptin 100 mg Plus Metformin | Change From Baseline (BL) in Glycosylated Hemoglobin (HbA1c) at Week 104 | -0.28 Percentage of HbA1c in the blood | Standard Error 0.065 |
| Glimepiride 2 mg Plus Metformin | Change From Baseline (BL) in Glycosylated Hemoglobin (HbA1c) at Week 104 | -0.36 Percentage of HbA1c in the blood | Standard Error 0.064 |
| Albiglutide 30 mg Plus Metformin | Change From Baseline (BL) in Glycosylated Hemoglobin (HbA1c) at Week 104 | -0.63 Percentage of HbA1c in the blood | Standard Error 0.065 |
95% CI: [-1.16, -0.65]ANCOVA
95% CI: [-0.53, -0.17]ANCOVA
95% CI: [-0.45, -0.09]ANCOVA
p-value: <0.0001t-test, 2 sided
p-value: <0.0001t-test, 1 sided
p-value: <0.0001t-test, 1 sided
p-value: 0.0001t-test, 2 sided
p-value: 0.0033t-test, 2 sided
Secondary
Change From Baseline in Body Weight at Week 104
The Baseline value is the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline weight minus the Baseline weight. The LOCF method was used to impute missing post-Baseline weight values. Weight values obtained after hyperglycemia rescue were treated as missing and replaced with prerescue values. Based on ANCOVA: change = treatment + Baseline weight + Baseline HbA1c category + prior myocardial infarction history + age category + region.
Time frame: Baseline and Week 104
Population: ITT Population with LOCF. Only those participants with a value at Baseline and at the specified visit were analyzed. Values were carried forward for participants who were rescued or discontinued from active treatment before Week 104.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo Plus Metformin | Change From Baseline in Body Weight at Week 104 | -1.00 Kilograms | Standard Error 0.411 |
| Sitagliptin 100 mg Plus Metformin | Change From Baseline in Body Weight at Week 104 | -0.86 Kilograms | Standard Error 0.237 |
| Glimepiride 2 mg Plus Metformin | Change From Baseline in Body Weight at Week 104 | 1.17 Kilograms | Standard Error 0.237 |
| Albiglutide 30 mg Plus Metformin | Change From Baseline in Body Weight at Week 104 | -1.21 Kilograms | Standard Error 0.239 |
Secondary
Change From Baseline in Body Weight at Week 156
The Baseline value is the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline weight minus the Baseline weight. This analysis used observed body weight values excluding those obtained after hyperglycemia rescue; no missing data imputation was performed.
Time frame: Baseline and Week 156
Population: ITT Population with observed values. Only those participants who were available at the indicated time points were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo Plus Metformin | Change From Baseline in Body Weight at Week 156 | -3.61 Kilograms | Standard Deviation 3.46 |
| Sitagliptin 100 mg Plus Metformin | Change From Baseline in Body Weight at Week 156 | -2.05 Kilograms | Standard Deviation 4.109 |
| Glimepiride 2 mg Plus Metformin | Change From Baseline in Body Weight at Week 156 | 0.98 Kilograms | Standard Deviation 4.76 |
| Albiglutide 30 mg Plus Metformin | Change From Baseline in Body Weight at Week 156 | -2.31 Kilograms | Standard Deviation 5.093 |
Secondary
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 104
The FPG test measures blood sugar levels after the participant has not eaten (fasted) for 12 to 14 hours. The Baseline FPG value is the last non-missing value before the start of treatment. The LOCF method was used to impute missing post-Baseline FPG values. FPG values obtained after hyperglycemia rescue were treated as missing and replaced with pre-rescue values. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Based on ANCOVA: change = treatment + Baseline FPG + Baseline HbA1c category + prior myocardial infarction history + age category + region.
Time frame: Baseline and Week 104
Population: Intent-to-Treat (ITT) Population with LOCF. Only those participants with a value at Baseline and at the specified visit were analyzed. Values were carried forward for participants who were rescued or discontinued from active treatment before Week 104.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo Plus Metformin | Change From Baseline in Fasting Plasma Glucose (FPG) at Week 104 | 0.55 Millimoles per liter (mmol/L) | Standard Error 0.277 |
| Sitagliptin 100 mg Plus Metformin | Change From Baseline in Fasting Plasma Glucose (FPG) at Week 104 | -0.12 Millimoles per liter (mmol/L) | Standard Error 0.16 |
| Glimepiride 2 mg Plus Metformin | Change From Baseline in Fasting Plasma Glucose (FPG) at Week 104 | -0.41 Millimoles per liter (mmol/L) | Standard Error 0.159 |
| Albiglutide 30 mg Plus Metformin | Change From Baseline in Fasting Plasma Glucose (FPG) at Week 104 | -0.98 Millimoles per liter (mmol/L) | Standard Error 0.161 |
Secondary
Change From Baseline in FPG at Week 156
The FPG test measures blood sugar levels after the participant has not eaten (fasted) for 12 to 14 hours. The Baseline FPG value is the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. This analysis used observed FPG values excluding those obtained after hyperglycemia rescue; no missing data imputation was performed.
Time frame: Baseline and Week 156
Population: ITT Population with observed values. Only those participants with a value at Baseline and at the specified visit were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo Plus Metformin | Change From Baseline in FPG at Week 156 | -0.11 Millimoles per liter (mmol/L) | Standard Deviation 1.498 |
| Sitagliptin 100 mg Plus Metformin | Change From Baseline in FPG at Week 156 | -0.50 Millimoles per liter (mmol/L) | Standard Deviation 2.519 |
| Glimepiride 2 mg Plus Metformin | Change From Baseline in FPG at Week 156 | -0.71 Millimoles per liter (mmol/L) | Standard Deviation 2.684 |
| Albiglutide 30 mg Plus Metformin | Change From Baseline in FPG at Week 156 | -1.30 Millimoles per liter (mmol/L) | Standard Deviation 2.602 |
Secondary
Change From Baseline in HbA1c at Week 156
HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3-month period. Baseline HbA1c value is defined as the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. This analysis used observed HbA1c values, excluding those obtained after hyperglycemia rescue; no missing data imputation was performed .
Time frame: Baseline and Week 156
Population: Intent-to-Treat (ITT) Population with observed values. Only those par. with a value at Baseline and at the specified visit were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo Plus Metformin | Change From Baseline in HbA1c at Week 156 | -0.46 Percentage of HbA1c in the blood | Standard Deviation 0.82 |
| Sitagliptin 100 mg Plus Metformin | Change From Baseline in HbA1c at Week 156 | -0.56 Percentage of HbA1c in the blood | Standard Deviation 1.16 |
| Glimepiride 2 mg Plus Metformin | Change From Baseline in HbA1c at Week 156 | -0.59 Percentage of HbA1c in the blood | Standard Deviation 0.999 |
| Albiglutide 30 mg Plus Metformin | Change From Baseline in HbA1c at Week 156 | -0.88 Percentage of HbA1c in the blood | Standard Deviation 0.959 |
Secondary
Number of Participants Who Achieved Clinically Meaningful HbA1c Response Levels of <6.5%, <7%, and <7.5% at Week 104
The number of participants who achieved the HbA1c treatment goal (i.e., HbA1c response levels of \<6.5%, \<7%, and \<7.5% at Week 52) were assessed.
Time frame: Week 104
Population: ITT Population with LOCF. Only those participants with a value at Baseline and at the specified visit were analyzed. Values were carried forward for participants who were rescued or discontinued from active treatment before Week 104.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo Plus Metformin | Number of Participants Who Achieved Clinically Meaningful HbA1c Response Levels of <6.5%, <7%, and <7.5% at Week 104 | HbA1c <6.5% | 7 Participants |
| Placebo Plus Metformin | Number of Participants Who Achieved Clinically Meaningful HbA1c Response Levels of <6.5%, <7%, and <7.5% at Week 104 | HbA1c <7.5% | 27 Participants |
| Placebo Plus Metformin | Number of Participants Who Achieved Clinically Meaningful HbA1c Response Levels of <6.5%, <7%, and <7.5% at Week 104 | HbA1c <7.0% | 15 Participants |
| Sitagliptin 100 mg Plus Metformin | Number of Participants Who Achieved Clinically Meaningful HbA1c Response Levels of <6.5%, <7%, and <7.5% at Week 104 | HbA1c <6.5% | 45 Participants |
| Sitagliptin 100 mg Plus Metformin | Number of Participants Who Achieved Clinically Meaningful HbA1c Response Levels of <6.5%, <7%, and <7.5% at Week 104 | HbA1c <7.5% | 132 Participants |
| Sitagliptin 100 mg Plus Metformin | Number of Participants Who Achieved Clinically Meaningful HbA1c Response Levels of <6.5%, <7%, and <7.5% at Week 104 | HbA1c <7.0% | 94 Participants |
| Glimepiride 2 mg Plus Metformin | Number of Participants Who Achieved Clinically Meaningful HbA1c Response Levels of <6.5%, <7%, and <7.5% at Week 104 | HbA1c <7.0% | 94 Participants |
| Glimepiride 2 mg Plus Metformin | Number of Participants Who Achieved Clinically Meaningful HbA1c Response Levels of <6.5%, <7%, and <7.5% at Week 104 | HbA1c <6.5% | 40 Participants |
| Glimepiride 2 mg Plus Metformin | Number of Participants Who Achieved Clinically Meaningful HbA1c Response Levels of <6.5%, <7%, and <7.5% at Week 104 | HbA1c <7.5% | 147 Participants |
| Albiglutide 30 mg Plus Metformin | Number of Participants Who Achieved Clinically Meaningful HbA1c Response Levels of <6.5%, <7%, and <7.5% at Week 104 | HbA1c <6.5% | 50 Participants |
| Albiglutide 30 mg Plus Metformin | Number of Participants Who Achieved Clinically Meaningful HbA1c Response Levels of <6.5%, <7%, and <7.5% at Week 104 | HbA1c <7.5% | 172 Participants |
| Albiglutide 30 mg Plus Metformin | Number of Participants Who Achieved Clinically Meaningful HbA1c Response Levels of <6.5%, <7%, and <7.5% at Week 104 | HbA1c <7.0% | 113 Participants |
Secondary
Number of Participants Who Achieved Clinically Meaningful HbA1c Response Levels of <6.5%, <7%, and <7.5% at Week 156
The number of participants who achieved the HbA1c treatment goal (i.e., HbA1c response levels of \<6.5%, \<7%, and \<7.5% at Week 156) were assessed.
Time frame: Week 156
Population: ITT Population with observed values. Only those participants with a value at Baseline and at the specified visit were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo Plus Metformin | Number of Participants Who Achieved Clinically Meaningful HbA1c Response Levels of <6.5%, <7%, and <7.5% at Week 156 | HbA1c <7.0% | 7 Participants |
| Placebo Plus Metformin | Number of Participants Who Achieved Clinically Meaningful HbA1c Response Levels of <6.5%, <7%, and <7.5% at Week 156 | HbA1c <7.5% | 13 Participants |
| Placebo Plus Metformin | Number of Participants Who Achieved Clinically Meaningful HbA1c Response Levels of <6.5%, <7%, and <7.5% at Week 156 | HbA1c <6.5% | 4 Participants |
| Sitagliptin 100 mg Plus Metformin | Number of Participants Who Achieved Clinically Meaningful HbA1c Response Levels of <6.5%, <7%, and <7.5% at Week 156 | HbA1c <6.5% | 23 Participants |
| Sitagliptin 100 mg Plus Metformin | Number of Participants Who Achieved Clinically Meaningful HbA1c Response Levels of <6.5%, <7%, and <7.5% at Week 156 | HbA1c <7.5% | 69 Participants |
| Sitagliptin 100 mg Plus Metformin | Number of Participants Who Achieved Clinically Meaningful HbA1c Response Levels of <6.5%, <7%, and <7.5% at Week 156 | HbA1c <7.0% | 44 Participants |
| Glimepiride 2 mg Plus Metformin | Number of Participants Who Achieved Clinically Meaningful HbA1c Response Levels of <6.5%, <7%, and <7.5% at Week 156 | HbA1c <7.0% | 44 Participants |
| Glimepiride 2 mg Plus Metformin | Number of Participants Who Achieved Clinically Meaningful HbA1c Response Levels of <6.5%, <7%, and <7.5% at Week 156 | HbA1c <6.5% | 15 Participants |
| Glimepiride 2 mg Plus Metformin | Number of Participants Who Achieved Clinically Meaningful HbA1c Response Levels of <6.5%, <7%, and <7.5% at Week 156 | HbA1c <7.5% | 69 Participants |
| Albiglutide 30 mg Plus Metformin | Number of Participants Who Achieved Clinically Meaningful HbA1c Response Levels of <6.5%, <7%, and <7.5% at Week 156 | HbA1c <6.5% | 31 Participants |
| Albiglutide 30 mg Plus Metformin | Number of Participants Who Achieved Clinically Meaningful HbA1c Response Levels of <6.5%, <7%, and <7.5% at Week 156 | HbA1c <7.5% | 90 Participants |
| Albiglutide 30 mg Plus Metformin | Number of Participants Who Achieved Clinically Meaningful HbA1c Response Levels of <6.5%, <7%, and <7.5% at Week 156 | HbA1c <7.0% | 69 Participants |
Secondary
Time to Hyperglycemia Rescue
Participants who experienced persistent hyperglycemia (high blood glucose) could have qualified for hyperglycemia rescue.The conditions for hyperglycemic rescue were as follows: FPG \>=280 milligrams/deciliter (mg/dL) between \>=Week 2 and \<Week 4; FPG \>=250 mg/dL between \>=Week 4 and \<Week 12; HbA1c \>=8.5% and a \<=0.5% reduction from Baseline between \>=Week 12 and \<Week 24; HbA1c \>=8.5% between \>=Week 24 and \<Week 48; HbA1c \>=8.0% between \>= Week 48 and \<Week 156. Participants could have been rescued at any time on or after Week 2. Time to hyperglycemia rescue is defined as the time between the date of the first dose of study medication and the date of hyperglycemia rescue plus 1 day, or the time between the date of the first dose of study medication and the date of the last visit during the active treatment period plus 1 day for participants not requiring rescue. This time was divided by 7 to express the result in week
Time frame: From the start of study medication until the end of the treatment (up to Week 156)
Population: ITT Population. Only those participants with a value at Baseline and at the specified visit were analyzed.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo Plus Metformin | Time to Hyperglycemia Rescue | 67.71 Weeks |
| Sitagliptin 100 mg Plus Metformin | Time to Hyperglycemia Rescue | NA Weeks |
| Glimepiride 2 mg Plus Metformin | Time to Hyperglycemia Rescue | NA Weeks |
| Albiglutide 30 mg Plus Metformin | Time to Hyperglycemia Rescue | NA Weeks |